CRE Wireguided 15-18mm 240cm

Published: July 8, 2026Recall ID: Z-2636-2026Category: devicesCountry: US

Reason for Recall / Hazard

Potential sterile breach of the pouches in which devices are packaged.

Field	Value
City	Marlborough
State	MA
Event id	99067
Address 1	100 Boston Scientific Way
Address 2	N/A
Code info	UPN: M00558490; GTIN: 8714729339427; Lot No. 38033568, 38033569, 38033570, 38033571, 38047498, 38047722, 38047731, 38200167, 38239090, 38325015, 38325016, 38325017, 38413205, 38413206, 38413207, 38413208, 38413214, 38422540, 38422541, 38422542, 38422543, 38479759, 38507303, 38507304, 38519497, 38519498, 38529540, 38529541, 38529542, 38529543, 38529544, 38585005, 38585006, 38647771, 38790079, 38817673, 38817674, 38817675, 38817676, 38817677, 38817678, 38817679; Exp. October 24, 2028 February 9, 2029.
Postal code	01752-1234
Report date	20260708
Product type	Devices
Product quantity	81,543 units
Reason for recall	Potential sterile breach of the pouches in which devices are packaged.
Voluntary mandated	Voluntary: Firm initiated
Recall initiation date	20260521
Initial firm notification	Letter
Center classification date	20260701

Recalling FirmBoston Scientific Corporation
StatusOngoing
Risk LevelClass II
DistributionWorldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Bangladesh, Belgium, Bulgaria, Canada, Chile, China, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Estonia, Finland, France, Germany, Great Britain, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Mongolia, Netherlands, New Zealand, Norway, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tobago, Trinidad, Tunisia, T¿rkiye, United Arab Emirates, Uruguay.